Acrobat-i PositionerRecalls & reported problems across all models

We found 2 models of Acrobat-i Positioner by Maquet Cardiovascular LLC in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Sep 10, 2020 and Mar 16, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (16 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Acrobat-i Positioner recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 16, 2024Open, Classified

   Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

   Z-0484-2025 · Root cause: Process change control · Recall details · FDA record ↗

2. Oct 31, 2023Open, Classified

   The Positioner Arm may not tighten or lock during normal use.

   Z-0589-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported Acrobat-i Positioner problems

Acrobat-i Positioner models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Acrobat-i Positioner XP-5000Z

  Stabilizer,Heart
  2 recalls34 reports
• Acrobat-i Positioner XP-5000

  Stabilizer,Heart
  14 reports

Recent Acrobat-i Positioner adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Mechanical Problem

  THE HOSPITAL REPORTED THAT WHEN THE SURGEON ATTEMPTED TO SECURE THE ACROBAT-I STABILIZER DURING AN OPCAB PROCEDURE, FOLLOWING THE IFU INSTRUCTIONS, THE DEVICE FAILED TO LOCK. THE HARVESTER ATTEMPTED SEVERAL MORE TIMES, BUT THE SAME ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. THE PATIENT'S CONDITION WAS NORMAL. THERE WAS A 15-MINUTE DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603986 ↗
• MalfunctionFeb 4, 2026Mechanical Problem

  THE HOSPITAL REPORTED THAT THE ACROBAT-I POSITIONER HANDLE WOULD NOT TIGHTEN. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE CASE WITHOUT ISSUE. NO DEALY. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256544 ↗
• MalfunctionJun 11, 2025Suction Problem; Suction Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191203 ↗
• MalfunctionMay 20, 2025Positioning Problem; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I POSITIONER, THE POSITIONER WOULD NOT LOCK IN PLACE EVEN WHEN I TURNED THE KNOB. THE ONLY TROUBLESHOOTING STEP TAKEN WAS RESOLVED BY USING A NEW DEVICE. THERE WAS NO SIGNIFICANT DELAY. THERE WAS NO SIGNIFICANT IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054606 ↗
• MalfunctionFeb 10, 2025Suction Failure; Suction Failure

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351645 ↗
• MalfunctionDec 21, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 CAUTERY STOPPED WORKING WHILE CAUTERIZING A BRANCH. IT RESUMED AFTER 15-20 SECONDS, BUT THEN STOPPED WORKING AGAIN. IT'S LIKELY THE POLYFUSE FEATURE WAS IN EFFECT, BUT IT'S NOT KNOWN. ANOTHER KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR DELAY IN THE PROCEDURE - ASIDE FROM THE FEW MINUTES TO OPEN ANOTHER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376085 ↗
• MalfunctionDec 8, 2023Suction Failure; Suction Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290810 ↗
• MalfunctionAug 29, 2023Suction Problem; Suction Problem

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I POSITIONER, THEY SAID THAT WHEN THEY WERE INSTALLING THE ACROBAT-I POSITIONER ON PLATFORM AND LOCK LEVER LOCKER IS AT LOCK POSITION BUT IS NOT WORKING FUNCTIONAL. THE ANGLE OF ACROBAT-I SWIVEL SHOULD PROVIDE 180 DEGREE SIDE-TO-SIDE RANGE OF MOTION OF THE ARM AND 90 DEGREE VERTICAL DROP AND SUCTION CUP SHOULD FIXED WHEN OPENING VACUUM PRESSURE BUT IN SOME OF ANGLE IT STUCK AND CAN NOT FIX FOR THE PARTICULAR ANGLE. SO THEY DECIDED TO REPLACE IT WITH A NEW ONE IMMEDIATELY WITHOUT USING ON THE PATIENT. THERE IS NO PROCEDURAL DELAY. THERE WAS NO HARM DUE TO THE POTENTIAL HARM PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644875 ↗
• MalfunctionMar 13, 2023Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT-I POSITIONER MALFUNCTIONED; DID NOT TIGHTEN. A SECOND UNIT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529582 ↗
• MalfunctionJan 24, 2023Mechanical Problem; Mechanical Problem

  TRACKWISE ID (B)(6). THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE ACROBAT-I POSITIONER WOULDN'T LOCK INTO PLACE WHEN MOVING IT TO THE BACK OF THE HEART. THE MALFUNCTION HAPPENED TWICE IN THE SAME CASE. A NEW BOX WAS OPENED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16238030 ↗
• MalfunctionJan 24, 2023Mechanical Problem; Mechanical Problem

  RELATED TO 745360. THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE ACROBAT-I POSITIONER WOULDN'T LOCK INTO PLACE WHEN MOVING IT TO THE BACK OF THE HEART. THE MALFUNCTION HAPPENED TWICE IN THE SAME CASE. A NEW BOX WAS OPENED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237640 ↗
• MalfunctionNov 30, 2022Suction Failure; Suction Failure

  THE HOSPITAL REPORTED THAT A ACROBAT-I POSITIONER USED FOR A CORONARY ARTERY BYPASS PROCEDURE SUCTION CUP WAS STUCK AND CANNOT BE USED NORMALLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887707 ↗
• MalfunctionNov 22, 2022Break; Positioning Failure; Break; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE ACROBAT-I POSITIONER CH KNOB BROKE AND WOULDN'T TIGHTEN. KNOB WOULDN¿T LOCK INTO PLACE. A NEW KIT OPENED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845836 ↗
• MalfunctionNov 7, 2022Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE ACROBAT-I POSITIONER CH ARM WOULD NOT TIGHTEN ALL THE WAY ENOUGH TO HOLD THE HEART UP. THEY OPENED UP ANOTHER ONE TO FINISH THE CASE WITH NO PATIENT AFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743126 ↗
• MalfunctionNov 1, 2022Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709309 ↗

Other Maquet Cardiovascular LLC products

• Vasoview Hemopro2 models · 646 reports · 6 recalls
• Acrobat-I Stabilizer2 models · 171 reports · 3 recalls
• Acrobat SUV Stabilizer2 models · 22 reports · 2 recalls